DELTA Cup Instrument Set 9055.50.225

GUDID 08033390025386

Trial Liner #SMALL for Head dia=32mm

LIMACORPORATE SPA

Acetabulum prosthesis trial, prefabricated, reusable

• Primary Device ID: 08033390025386
• NIH Device Record Key: cb54b46e-b517-4b8f-a513-abe869ee65ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DELTA Cup Instrument Set
• Version Model Number: Trial Liner
• Catalog Number: 9055.50.225
• Company DUNS: 432066322
• Company Name: LIMACORPORATE SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

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• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033390025386 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112898

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08033390025386]

Moist Heat or Steam Sterilization

[08033390025386]

Moist Heat or Steam Sterilization

[08033390025386]

Moist Heat or Steam Sterilization

[08033390025386]

Moist Heat or Steam Sterilization

[08033390025386]

Moist Heat or Steam Sterilization

[08033390025386]

Moist Heat or Steam Sterilization

[08033390025386]

Moist Heat or Steam Sterilization

[08033390025386]

Moist Heat or Steam Sterilization

[08033390025386]

Moist Heat or Steam Sterilization

[08033390025386]

Moist Heat or Steam Sterilization

[08033390025386]

Moist Heat or Steam Sterilization

[08033390025386]

Moist Heat or Steam Sterilization

[08033390025386]

Moist Heat or Steam Sterilization

[08033390025386]

Moist Heat or Steam Sterilization

[08033390025386]

Moist Heat or Steam Sterilization

[08033390025386]

Moist Heat or Steam Sterilization

[08033390025386]

Moist Heat or Steam Sterilization

[08033390025386]

Moist Heat or Steam Sterilization

[08033390025386]

Moist Heat or Steam Sterilization

[08033390025386]

Moist Heat or Steam Sterilization

[08033390025386]

Moist Heat or Steam Sterilization

[08033390025386]

Moist Heat or Steam Sterilization

[08033390025386]

Moist Heat or Steam Sterilization

[08033390025386]

Moist Heat or Steam Sterilization

[08033390025386]

Moist Heat or Steam Sterilization

[08033390025386]

Moist Heat or Steam Sterilization

[08033390025386]

Moist Heat or Steam Sterilization

[08033390025386]

Moist Heat or Steam Sterilization

[08033390025386]

Moist Heat or Steam Sterilization

[08033390025386]

Moist Heat or Steam Sterilization

[08033390025386]

Moist Heat or Steam Sterilization

[08033390025386]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-12-21
• Device Publish Date: 2016-06-17

On-Brand Devices [DELTA Cup Instrument Set]

• 08033390057561: Trial Liner #LARGE for Head dia=40mm
• 08033390025393: Trial Liner #SMALL for Head dia=36mm
• 08033390025386: Trial Liner #SMALL for Head dia=32mm
• 08033390025379: Trial Liner #SMALL for Head dia=28mm
• 08033390025362: Trial Liner #MEDIUM for Head dia=36mm
• 08033390025355: Trial Liner #MEDIUM for Head dia=32mm
• 08033390025348: Trial Liner #MEDIUM for Head dia=28mm
• 08033390025331: Trial Liner #LARGE for Head dia=36mm
• 08033390025324: Trial Liner #LARGE for Head dia=32mm
• 08033390025317: Trial Liner #LARGE for Head dia=28mm